Search Results

The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.

Each package of the Yoni.Fit® Bladder Support comes with the following:

• 3 reusable Yōni.Fit® Bladder Supports for sizing .
• . Cleaning brush
• Storage case ●
• Instructions for Use ●

The provided text describes the 510(k) summary for the Yoni.Fit® Bladder Support, a vaginal pessary intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women. While it details clinical performance data, it does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, based on the provided information, we can extract the relevant details to construct a response.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined acceptance criteria for the clinical study. Instead, it describes its primary effectiveness endpoint and the achieved results. We can infer the "acceptance criteria" from the goal of the study – to show a statistically significantly higher responder rate compared to the control.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Clinical Study):

  • Total participants enrolled and randomized: 58 (31 Yōni.Fit® and 27 control)
  • Participants completing treatment phase: 56
  • Participants continuing to open label phase: 54
  • Participants completing 30 days of safety follow-up: 42
  • Participants completing 6 weeks of safety follow-up: 38
  • Participants with completely missing efficacy data (considered non-responders for analysis): 4 (2 Yōni.Fit®, 2 control)

• Data Provenance:

  • Country of Origin: Three US sites.
  • Study Type: Prospective, randomized, comparator-controlled, single blinded, multicenter crossover study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The study evaluates the effectiveness of a medical device for stress urinary incontinence using patient-reported outcomes (questionnaires) and objective measurements (12-hour pad weights, voiding diaries). The "ground truth" for efficacy is based on objective measurement of urine leakage (pad weights) and patient-reported symptoms, not expert interpretation of diagnostic images or pathology. Therefore, there is no mention of experts establishing ground truth in the context of diagnostic interpretation. The study was conducted by medical professionals, and participants were diagnosed with SUI by both a cough supine test and a history of SUI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe an adjudication method for establishing ground truth, as the primary effectiveness endpoint was based on quantitative measurements (pad weights) and participant questionnaires. Medical staff and investigators would have managed data collection and study conduct, but there's no mention of a specific adjudication panel for results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for AI/CADe (Computer-Aided Detection/Diagnosis) devices where human readers interpret medical images with and without AI assistance. The Yoni.Fit® Bladder Support is a physical medical device, not a software or AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. As mentioned, the Yoni.Fit® Bladder Support is a physical device inserted by the patient (after physician fitting/prescription) for direct therapeutic effect, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical effectiveness study was based on:

• Outcomes Data: Primarily objective measurements of urine leakage (average 12-hour pad weights) and patient-reported outcomes from questionnaires.
• Clinical Diagnosis: Participants were diagnosed with SUI by a cough supine test and a history of SUI prior to enrollment.

8. The sample size for the training set

The document describes a clinical study to evaluate the safety and effectiveness of the device, which serves as a pivotal study for regulatory approval. It does not mention a "training set" in the context of machine learning, as this is a physical medical device and not an AI/ML algorithm.

9. How the ground truth for the training set was established

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable based on the provided document. The clinical study was designed to test the device's performance against a control, not to train an algorithm.

Ask a specific question about this device